A consumer blood thinner lawsuit was recently filed alleging that use of Xarelto can cause serious bleeding events.

Plaintiff Sharon R. recently filed a blood thinner lawsuit against numerous pharmaceutical companies including Janssen, Johnson & Johnson, and Bayer, alleging that Xarelto caused her to suffer from a serious internal bleed.

Sharon says she was prescribed Xarelto in 2016 when she suffered from a severe bleeding event which she alleges was a direct result of her treatment with the blood thinner.

Xarelto (rivaroxaban) is a blood thinning drug often prescribed to prevent clotting and reduce the risk of stroke in at-risk patients. At-risk patients include those with an irregular heart rhythm known as nonvalvular atrial fibrillation, those with current or previous deep vein thrombosis or pulmonary embolism, and those undergoing hip or knee replacement surgery.

Like many modern blood thinners, Xarelto has been forced to compete in the market with warfarin, the industry standard blood thinner trusted by patients and doctors for over 60 years. According to the blood thinner lawsuit, the drug was marketed heavily to compete with warfarin’s well known reputation.

Marketing emphasised the “Xarelto Difference,” once-a-day dosing and no blood testing requirements. As twice-a-day dosing and strict blood testing requirements are the top complaints regarding warfarin, defendants allegedly relied on the “Xarelto Difference” to market their product.

However, studies have shown that Xarelto may be more dangerous than warfarin. In the year leading up to June 2012, there were allegedly 1,080 adverse events associated with Xarelto reported to the U.S. Food and Drug Administration.

Of the 1,080 events, at least 65 resulted in death. In 2011, the ROCKET AF study showed that while Xarelto was non-inferior to warfarin, bleeding events while on Xarelto were far more common. Although the ROCKET AF results were used to increase approval for Xarelto uses, the FDA acknowledged that the usage of Xarelto was problematic.

The FDA Advisory Committee allegedly acknowledged that Xarelto’s safety profile would have been greatly improved if the manufacturer’s recommended twice a day dosing opposed to once daily. One scientist critiqued the once a day dosing more sharply, stating “my concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was a mistake.”

Sharon argues that the drug manufacturers knew about the risks associated with their products, and knew that changing dosing recommendations would benefit the safety profile of the drug. According to the blood thinner lawsuit, the manufacturers chose to ignore these facts. By not changing the drug to be safer, the defendants allegedly prioritized profits over patient safety.

Sharon accuses the defendants of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, fraud, violation of consumer protection laws, and loss of consortium.

The blood thinner lawsuit seeks compensatory damages, economic damages, punitive damages, court costs and attorneys’ fees.

The Xarelto Blood Thinner Lawsuit is Case No. 2:18-cv-06382-EEF-MBN in the United States District Court for the Eastern District of Louisiana.